Health Canada approves Moderna's mRNA flu and flu-COVID combo vaccines: what Canadians need to know

This article is for informational purposes only and is not medical advice. Consult your Canadian healthcare provider about your situation.

Health Canada authorized two new Moderna mRNA-based influenza products on November 5, 2026: a standalone mRNA flu vaccine and a combination flu-COVID-19 shot, making Canada the first country to grant regulatory approval to an mRNA influenza product for general use. For Canadians, the authorization means these vaccines can now legally be sold and administered in this country, but that is not the same as saying they are available at your pharmacy tomorrow. Whether you can access either product this season depends on provincial procurement decisions, National Advisory Committee on Immunization (NACI) guidance, and whether your province's public health program funds the shot.

The two products are distinct. The standalone mRNA flu vaccine targets seasonal influenza strains using the same messenger-RNA platform Moderna used for its COVID-19 vaccine (sold in Canada as Spikevax). The combination product targets both influenza and SARS-CoV-2 in a single injection. Health Canada's authorization covers both, but the regulatory green light does not automatically trigger a publicly funded rollout. Canadians who want either vaccine may need to pay out of pocket at a pharmacy or private clinic until provincial formularies are updated, and prices have not yet been published by Moderna Canada.

What this means in Canada

Health Canada's authorization is the first regulatory gate, not the last. The next step is a NACI recommendation, which advises provinces and territories on who should receive a vaccine and under what priority. As of the date of this article, NACI has not issued a position statement on either Moderna mRNA flu product. Without that statement, most provincial immunization programs will not add the vaccines to their publicly funded schedules.

Provincial pharmacare coverage varies considerably. In Ontario, flu vaccines on the publicly funded schedule are available at no cost through OHIP-funded programs at pharmacies and public health units. Quebec's Régie de l'assurance maladie du Québec (RAMQ) covers flu shots for priority populations. British Columbia's MSP-linked immunization program and Alberta's AHCIP-funded schedule follow similar structures. None of these programs have announced plans to add the new Moderna mRNA flu products for the 2026-27 season, and it would be premature to expect them to do so before NACI weighs in.

For Canadians who want the combination flu-COVID shot specifically, the situation is similar to where Spikevax stood in late 2021: authorized but not yet universally covered. Private purchase through a pharmacy is likely the first access point, at a cost that has not been publicly confirmed.

What changed

Until this authorization, every flu vaccine available in Canada used either an egg-based or cell-based manufacturing process. mRNA flu vaccines work differently: instead of growing inactivated virus in eggs or cell cultures, they deliver genetic instructions that prompt the body to produce a protein that triggers an immune response. Moderna's clinical trial data, submitted to Health Canada as part of the authorization package, showed the mRNA flu vaccine produced immune responses non-inferior to existing egg-based flu shots. The combination product's trial data covered both flu and COVID-19 endpoints.

The US Food and Drug Administration (FDA) has not yet authorized an mRNA flu vaccine as of this writing, meaning Health Canada's approval actually precedes the FDA's on this product class. That is notable because Canadian regulators often follow FDA decisions on novel biologics, not the reverse.

The mRNA platform also offers a manufacturing speed advantage. Traditional egg-based flu vaccines take roughly six months to produce at scale. mRNA vaccines can be reformulated and manufactured faster, which matters if the circulating flu strain drifts significantly from the predicted strain after production has begun.

What Canadian patients should know

If you are deciding whether to get a flu shot this season, the standard egg-based and cell-based flu vaccines already authorized and publicly funded in your province remain your most accessible option right now. They are available at pharmacies across the country and are covered for priority populations (adults 65 and older, pregnant people, young children, and those with certain chronic conditions) in every province.

If you are specifically interested in the new Moderna mRNA flu vaccine or the combination flu-COVID shot, ask your pharmacist whether the product has been stocked and what the out-of-pocket cost would be. Some private pharmacies may begin carrying the standalone mRNA flu vaccine before provincial programs fund it, similar to how some Canadians paid privately for updated COVID boosters before provincial coverage was extended.

For people who would otherwise need both a flu shot and a COVID booster this fall, the combination product is conceptually appealing as a single injection. Whether the convenience justifies any additional cost is a conversation to have with your physician or pharmacist, particularly if you have a history of reactions to either vaccine component.

People who are immunocompromised, pregnant, or managing chronic conditions that put them at higher risk from influenza should not delay their flu shot waiting for the new mRNA products to become publicly funded. The existing publicly funded vaccines are effective and available now.

Limitations and open questions

Several things are genuinely unknown at this point. NACI has not issued a recommendation. No province has announced formulary coverage. Moderna Canada has not published a retail price for either product. The clinical trial data supporting authorization has not yet been published in a peer-reviewed journal that is publicly accessible, so independent assessment of the efficacy and safety data is not yet possible.

It is also not clear whether the combination flu-COVID vaccine will be recommended as a replacement for separate flu and COVID boosters, or as an option for people who want convenience. NACI's eventual guidance will address this, but the timeline for that guidance is not known.

Longer term, the mRNA platform's speed advantage in responding to strain drift has not yet been tested in a real-world flu season. The 2026-27 season will be the first opportunity to see whether the manufacturing flexibility translates into better strain matching than egg-based vaccines typically achieve.

The SOGC (Society of Obstetricians and Gynaecologists of Canada) has not issued specific guidance on the new mRNA flu products for pregnant people. Flu vaccination during pregnancy is strongly recommended by the SOGC using existing authorized vaccines. Whether the new mRNA products will carry the same recommendation for pregnant patients will depend on the trial data and NACI's review.

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This article is for informational purposes only and is not medical advice. Consult your Canadian healthcare provider about your situation.

Editorial note

Hormone Journal articles are written by our editorial team and reviewed against published clinical guidelines, with a focus on Canadian patient access. We do not promote specific clinics or providers.